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The FDA is failing to protect the public

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Saturday February 2, 2013 7:11 AM

As a laboratory technician who screens Pap smears, I was not at all surprised to read about the
difficulties experienced by activists in protesting to the Food and Drug Administration regarding
harmful food additives (“U.S. allows food additives others ban,”
Chicago Tribune article, Sunday
Dispatch). Many lab techs have been required to use a computerized microscope, the
performance of which appears inconsistent with its advertising.

Around 2003, a corporation announced that it had produced a computerized microscope of
extraordinary accuracy for screening Pap smears. The FDA approved the device, and my laboratory
procured it.

We became alarmed at the tendency of the device to miss abnormal cellularity if it is present in
large clusters. Supervisors initiated measures for extensive oversight of the instrument.

Then studies surfaced that claimed the device is no more accurate than manual screening. Studies
also contradicted the advertising of other Pap-smear products from the same manufacturer.

We protested to the FDA, but essentially nothing happened.

Then articles appeared that strongly suggest that the FDA is failing in its responsibilities. In
an April 2008
Reader's Digest article, “Can We Trust the FDA?” the author wrote, “The agency is in
crisis, one shocking lapse after another, lurching from one disaster to the next.”

In an Aug. 23, 2010,
Time article “Is the FDA on drugs?” the authors detailed how the profitable diabetes drug
Avandia, with known dangerous side effects, was slipped past federal regulators.

On July 15, 2012,
The Dispatch published the
New York Times article, “FDA spied on upset scientists, records show.” The scandal
involved the FDA section that reviews medical devices. Was the computerized microscope involved
there?

Many lab techs believe that this microscope is simply high-tech swindling. At the very least, it
is not worth the money spent on it; at worst, it poses safety risks. It could well be that many
medical devices in mammography, colonoscopy and more are similarly fraudulent and potentially
dangerous.